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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955558
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/10/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during continuous renal replacement therapy (crrt) using a prismax control unit, the nurse set the rate to high and ¿mixed up¿ the pre-blood pump and patient fluid removal rates.It was reported the patient became dehydrated and unstable no further details).There was no report of medical invention associated with this event.No additional information is available.
 
Manufacturer Narrative
Additional information regarding, an ncr was inadvertently omitted in the follow up mdr.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
H10: a device history review revealed, no issues that could have caused or contributed to the reported issue.The device was not returned.Therefore, a device analysis could not be completed.However, the reported event of use error of ¿mixing up¿, the pre-blood pump and patient fluid removal rates is considered confirmed, based on customer report.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
PRISMAX
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11041613
MDR Text Key222647642
Report Number1416980-2020-07919
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
PMA/PMN Number
K190910
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number955558
Was Device Available for Evaluation? No
Date Manufacturer Received03/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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